NCT04547907 A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
| NCT ID | NCT04547907 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Henan Cancer Hospital |
| Condition | Breast Cancer,HER2-positive |
| Study Type | INTERVENTIONAL |
| Enrollment | 688 participants |
| Start Date | 2020-09-18 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 688 participants in total. It began in 2020-09-18 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-70 years; 2. Clinical T2-T4d, or T1c with axillary lymph node positivity; 3. Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay； 4. Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization; 5. No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy: 1. Neutrophil count absolute value ≧2.0×109/L; 2. Hemoglobin ≧ 100g/L; 3. Platelet count ≧100×109/L; 4. Total bilirubin \<1.5 ULN (upper limit of normal); 5. Creatinine \< 1.5×ULN 6. AST/ALT \< 1.5×ULN; 6. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%); 7. Reproductive age women, negative serum pregnancy test within 14 days before randomization; 8. ECOG score 0 or 1; 9. Signature of informed consent. Exclusion Criteria: 1. Stage IV (metastatic) breast cancer; 2. Bilateral breast cancer; 3. Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease; 4. Patients with a second primary malignancy, except for adequately treated skin cancer; 5. Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures; 6. Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following: 1. History of heart failure or systolic dysfunction (LVEF \< 50%); 2. High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular conduction blocks (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block); 3. Angina pectoris requiring anti-anginal drug therapy; 4. Clinically significant valvular heart disease; 5. ECG showing a transmural myocardial infarction; 6. Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg); 7. Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated; 8. Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
Contact & Investigator
Zhenzhen Liu
PRINCIPAL INVESTIGATOR
Study Principal Investigator Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT04547907 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer,HER2-positive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04547907 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 688 participants.
Is NCT04547907 currently recruiting?
Yes, NCT04547907 is actively recruiting participants. Contact the research team at liuzhenzhen73@163.com for enrollment information.
Where is the NCT04547907 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT04547907 clinical trial?
NCT04547907 is sponsored by Henan Cancer Hospital. The principal investigator is Zhenzhen Liu at Study Principal Investigator Henan Cancer Hospital. The trial plans to enroll 688 participants.
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